The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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11501–11525 of 13802

  • HighFDA (Devices)·Z-1424-2022·2022-07-27

    Randox Cholesterol In Vitro Diagnostic Kits Fail Stated Performance Specifications

    Randox Cholesterol diagnostic kits fail to meet stated performance specifications. Calibration issues cause quality control results to fall outside acceptable ranges, potentially delaying test results.

    Product
    Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1441-2022·2022-07-27

    Nexiva IV Catheter Stopcock May Leak During Infusion

    Becton Dickinson is recalling specific lots of Nexiva IV catheters because the stopcock housing may leak, potentially interrupting treatment and exposing patients to infusate and biohazardous material.

    Product
    Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2022·2022-07-27

    BD Connecta Stopcock Without Extension Tube Recalled for Potential Leakage Risk

    Becton Dickinson & Company is recalling BD Connecta Stopcock units worldwide due to a potential housing leakage defect that could interrupt treatment or cause exposure to biohazardous material.

    Product
    BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1392-2022·2022-07-27

    GreenLight HPSEA Laser Fiber Recall Due to Card Incompatibility Error

    Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.

    Product
    GreenLight HPSEA Laser Fibers, UPN 0010-2092
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1423-2022·2022-07-27

    Soluble Transferrin Receptor Calibrator Recall Due to Lab Errors

    Randox Laboratories is recalling Soluble Transferrin Receptors Calibrator kits used in lab analyzers. The calibrators can produce incorrect test results, with some values potentially underestimated by up to 30 percent.

    Product
    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2022·2022-07-27

    Stryker Trevo Trak 21 Microcatheter recalled for missing carton product illustration

    Stryker Neurovascular is recalling 71 Trevo Trak 21 Microcatheter units because the product carton label is missing the required product drawing or illustration.

    Product
    Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF: 91415; TREVO NXT 4X28+TRAK21+CAT6 3-PACK - CE, REF:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2022·2022-07-27

    Laboratory Reagent Recalled Due to Inaccurate Calibration Curves

    Randox Laboratories is recalling Soluble Transferrin Receptor reagent (TF10159) due to calibration curve defects causing inaccurate test results on Siemens Atellica CH analyzers.

    Product
    Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1451-2022·2022-07-27

    LumiraDx SARS-CoV-2 Antibody Quality Control Recalled Due to Unauthorized Modification

    LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.

    Product
    LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1404-2022·2022-07-27

    X80 RADiant Photoelectric Therapy System Compatibility Issue

    Xstrahl Limited is recalling specific lot codes of the X80 RADiant Photoelectric Therapy System due to a potential compatibility issue with replacement treatment applicators. Devices were distributed in Florida, California, and Kentucky.

    Product
    X80 RADiant Photoelectric Therapy System
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1394-2022·2022-07-27

    Triton Sponge System Software Instructions Updated for Proper Sponge Handling

    Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.

    Product
    Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1390-2022·2022-07-27

    Erythropoietin Control Product Instructions Contain Incorrect CE Marking

    R & D Systems is replacing Instructions for Use (IFU) for Quantikine IVD Erythropoietin Human Serum Controls due to an incorrect CE marking designation that should not appear on the self-certified product.

    Product
    Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1393-2022·2022-07-27

    NeuRx Diaphragm Pacing System Labeling Revised for Storage Clarity

    Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.

    Product
    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing S
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1349-2022·2022-07-20

    CoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports

    Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.

    Product
    CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1352-2022·2022-07-20

    MiniMed 620G insulin pump battery cap deterioration may cause power loss

    Medtronic MiniMed 620G insulin pumps may experience battery cap deterioration, resulting in incomplete battery circuit and loss of power. Approximately 2,287 affected pumps have been distributed across the U.S.

    Product
    MiniMed 620G Insulin Pump (O.U.S. version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1360-2022·2022-07-20

    Isopure IsoMix PRO Mixing System Electrical Short Recall

    Isopure is recalling approximately 119 units of the Sodium Bicarbonate Mixing and Distribution System due to an electrical short causing a thermal event and device damage. No injuries reported.

    Product
    Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-1356-2022·2022-07-20

    MiniMed 720G Insulin Pump Recalled Due to Battery Cap Deterioration Risk

    Medtronic MiniMed is recalling approximately 575 MiniMed 720G Insulin Pumps due to battery cap deterioration that may result in power loss and device malfunction.

    Product
    MiniMed 720G Insulin Pump (O.U.S. Version)
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1370-2022·2022-07-20

    NATURALYTE Hemodialysis Dialysate Recalled Due to Unqualified Bottle Caps

    Fresenius Medical Care is recalling 656 cases of NATURALYTE Liquid Acid dialysate nationwide (lot 22CTAC106) because alternate bottle caps are not qualified for use, potentially compromising product integrity.

    Product
    NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1365-2022·2022-07-20

    Neonatal Transport System Oxygen Supply Component Pressure-Rating Defect

    Draeger Medical is recalling neonatal transport systems because an oxygen supply component is not rated for the system's working pressure. This affects 38 units distributed internationally but not in the United States.

    Product
    Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1378-2022·2022-07-20

    Modular orthopedic prosthesis recall due to intraoperative component locking

    Waldemar Link is recalling Endo Model Modular Femur and Tibia orthopedic prostheses because the blind screws on the tibial component cannot be loosened during surgery, potentially prolonging procedures.

    Product
    Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1379-2022·2022-07-20

    Tibial Prosthesis Component Recalled for Intraoperative Screw Loosening Defect

    Tibial prosthesis components may have blind screws that cannot be loosened during surgery, potentially requiring surgical procedure changes and extended operative time.

    Product
    Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1327-2022·2022-07-20

    Radiography System Firmware Flaw May Cause Incorrect Image Orientation and Dose

    Philips DigitalDiagnost 4 Flex/Value radiography systems have a firmware issue in the Wallstand VS2 board that may cause incorrect image orientation and radiation dosing. The defect affects 140 systems distributed nationwide.

    Product
    DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2022·2022-07-20

    Aesculap Micro Needleholder Recalled for Incorrect Size Labeling

    Aesculap Implant Systems LLC is recalling TC Cooely Micro Needleholder instruments because units labeled as 200mm are actually 150mm. This labeling error could impact surgical procedures.

    Product
    AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1362-2022·2022-07-20

    Pressure Monitoring Sets with Excess Coating Pose Embolism Risk

    Cook Incorporated is recalling approximately 11,451 Pressure Monitoring Sets because excess coating material on the needle component may enter the bloodstream, potentially causing pulmonary embolism or ischemia.

    Product
    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1382-2022·2022-07-20

    Vivo 45LS Ventilator processor failure alarm not generated on shutdown

    Breas Medical recalls 1,113 Vivo 45LS Ventilators due to a processor that can fail without triggering an alarm, potentially preventing detection of ventilator malfunction if monitoring instructions are not followed.

    Product
    Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2022·2022-07-20

    HAMILTON-H900 Humidifier Recall Due to Delayed Low-Water Alarm

    Hamilton Medical's HAMILTON-H900 humidifier (models 950001, 950004) is recalled due to delayed low-water level alarms that may prevent medical staff from detecting an empty chamber during mechanical ventilation use.

    Product
    HAMILTON-H900 Humidifier, Models: 950001, 950004
    Category
    Medical Device
    Distribution
    6 states